Is it legal to submit a claim to Medicare for an off-label drug?
Submitting a claim to Medicare that includes a charge for an unapproved use of an “off-label” drug increases your risk of being in noncompliance with Medicare regulations issued by the Centers for Medicare and Medicaid Services (CMS) and by the U.S. Food and Drug Administration (FDA). The reason: If the charge does not meet the medical necessity standards, the government could construe it as a violation of the False Claims Act.
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